trending Market Intelligence /marketintelligence/en/news-insights/trending/6BiDRFto7arbLaEcaX42-A2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

FDA warns providers of surgical staplers' safety risks, may reclassify devices

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

FDA warns providers of surgical staplers' safety risks, may reclassify devices

The U.S. Food and Drug Administration sent a letter to healthcare providers warning them of safety risks associated with using surgical staplers and staples after an "increasing number of adverse events," including the continued reporting of deaths and serious injuries.

The agency issued a letter to healthcare providers March 8, saying that between Jan. 1, 2011 and March 31, 2018, the FDA received more than 32,000 individual reports of device malfunction, 9,000 reports of serious injuries and 366 reports of deaths.

Malfunctions include staplers misfiring during surgery, not firing at all mid-procedure, or firing the wrong type of staple, according to the FDA.

In the letter, the FDA provided a list of instructions on how best to use the surgical staplers and said it will hold a public comment period and a hearing regarding the safety of the medical devices in the near future, but did not give specific dates.

The FDA said it may reclassify surgical staplers and staples as class II medical devices, which would require stricter oversight of products before and after they go to market.

The letter was sent one day after Kaiser Health News published an investigative article about the FDA's medical device reporting program. According to the article, the FDA allowed certain companies to report malfunctions and injuries through an "alternative summary reporting" system. This system housed millions of reports that were kept in an obscure, internal system.

Medical device experts and even a former FDA commissioner were not aware that the system existed, according to Kaiser Health News.

While deaths are recorded in the FDA's public database manufacturer and user facility device experience, the article said serious injuries were reported through this alternate system for more than 100 medical devices, including surgical staplers and staples.

The FDA did include a link to the alternative summary report system in the March 8 letter.

The safety of medical devices has become a controversial issue for the FDA. Netflix Inc.'s documentary "The Bleeding Edge" criticized the agency's medical device approval process, saying the FDA knowingly allowed dangerous devices to go to market. The documentary specifically highlights Bayer AG's permanent birth control device Essure, which users claim has caused permanent injuries.

Bayer has defended the safety of the product, but said in 2018 it was pulling the device from U.S. markets due to poor sales.